36C25519Q0780-002.docx

36C25519Q0780

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25519Q0780 10-0 -2019 Seeler, Dana dana.seeler@va.gov 913-946-1977 10- -2019

10:00 AM CST

00255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X 334516 1000 Employees N/A X Y Department of Veterans Affairs

VISN 15

Multiple Locations See Delivery Schedule for Details Leavenworth KS 66048 00255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

00255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page This is to solicitation is to establish a Blanket Purchase Agreement for VISN 15 laboratories. The BPA will be for Automated Occult Blood Instrumentation (FIT) which susceptibility for the following facilities:

MARION VAMC, 401 West Main Street, Marion, IL 62959 KC VAMC, 4801 Linwood Blvd, Kansas City, Mo 64128 TOPEKA VAMC, 2200 Gage Blvd, Topeka, KS 66222 POPLAR BLUFF VAMC, 1500 N. Westwood Blvd, Poplar Bluff, MO COLUMBIA VAMC, 800 Hospital Drive, Columbia, MO 65201 ST LOUIS VAMC, 915 N Grand Blvd, St. Louis, MO WICHITA VAMC, 5500 East Kellogg, Wichita, KS 67218

SEE SECTION B, DELIVERY SCHEDULE FOR MORE DETAILS

Service-Disabled Veteran Owned Businesses and Veteran Owned Businesses must be Registered & CVE Certified in VetBiz.gov.

See CONTINUATION Page

SEE SECTION B.3

X X X One

DANA L SEELER

CONTRACTING OFFICER

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

Offeror DUNS #:

Company Name and Address:

Point of Contact:

Phone Number:

Email Address:

Tax ID#

GSA or VA NAC Contract Number

b. GOVERNMENT: Contracting Officer 36C255 Seeler, Dana L Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

1. BPA LANGUAGE

1.1 Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, VA Heartland Network (herein afterward referred as VISN #15) to establish a Cost-Per Reportable Result (CPT) Blanket Purchase Agreement (BPA) for standardized microbiology identification and susceptibility instrumentation. It is the intent of the Government to award this BPA to a single Contractor for the Susceptibility equipment. The BPA shall be under the FSS Contract, FSC (Federal Supply Class) Group 66 III Cost-Per-Test(CPT)/Cost Per Reportable Result(CPRR), Clinical Laboratory Analyzers. The term of the BPA must not exceed the expiration of the underling FSS contract. Contractor agrees to the following terms of the BPA exclusively with the VISN 15 facilities listed in Attachment 1. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract.

1.2 This BPA does not obligate any funds. Funds will be obligated on delivery orders by VISN 15 approved methods of payment for goods and services on individual delivery orders, as defined in the Statement of Requirements.

1.3 Prices and Terms VISN 15 will provide an estimated volume of tests performed as reflected in Attachment A for each individual medical center and/or outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes listed in the attached spreadsheet per facility, but does not guarantee volumes as listed; they are estimates ONLY.

1.4 TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA with one base year and four, one-year options to be exercised at the discretion of the Government and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor’s FSS contract. In addition, should a new FSS contract replace Contractor’s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 15 intends to establish the base year of the agreement for the period of June 1, 2019 through May 31, 2024.

1.5 IDENTIFICATION: Delivery Orders issued shall be identified by their applicable BPA Number. BPA identification numbers are assigned through the VHA Procurement Activity.

1.6 ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1 SCOPE OF PROCUREMENT

2.1.1 The instruments shall be able to simultaneously perform the testing as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

2.1.2 Delivery shall be in accordance with individual installation delivery orders and terms and conditions listed in the Statement of Work.

2.1.3 Only the NCO 15, Contracting Officer has the authority to enter into, administer, amend, modify or terminate this BPA. Once awarded a Contracting Officer Representative (COR) will be designated to oversee the daily functions of the BPA.

2.1.4 All orders placed against this Agreement shall only be processed by the NCO 15, Contracting Officer, otherwise order is void.

2.1.5 Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory.

2.1.6 If Contractor offers a family of analyzers, VISN 15 technical evaluation panel will determine if the instrumentation proposed meets needs of using facility. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities in Attachment A.

2.1.7 The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control bottles. Unexpected changes in methodology/technology shall be at the expense of the contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

2.1.8 The Contractor will assist with a holding tank for sites that use on demand orders. Contractor will work with the laboratory to determine adequate reagent volumes for contracted period.

2.1.9 Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal government test load volume). If additional requests for emergency supply delivery are required by the government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2.1.10 VISN 15 is soliciting quotes to provide the following standardized microbiology identification and susceptibility instrumentation. Complete requirements shall include specifications as listed below in the price schedule. All offerors shall include a copy of the equipment brochure which clearly defines the product that is being offered. Any information submitted by an offeror for consideration will not be returned and will remain the property of the VA.

2.2 DEFINITIONS

2.2.1 Cost per Test (CPT) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers- Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training in the operation of test equipment for Government personnel. Contractors are required to provide delivery, installation, maintenance and removal of equipment at no additional charge.

2.2.2 Business Associate Agreement (BAA)-A business associate is an entity, including an individual, company, or organization that, on behalf of Veterans Health Administration (VHA), performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. The awardee of this BPA is considered a business associate and will be required to enter into a BAA with VHA as a condition to this Agreement.

2.3 TEST MENU

Refer to Attachment A Price Schedule below for a list of desired tests and their estimated annual volumes.

2.4 GENERAL REQUIREMENTS

2.4.1 Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and must meet all technical specifications of this solicitation.

2.4.2 The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for minimally aerobic, facultative, and fastidious microorganisms.

2.4.3 The system shall have a data management system with varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles.

2.4.4 Operational Features - The instrumentation offered shall have the following optional features:

2.4.4.1 The capability of performing 100% of the tests listed in the Price Schedule below.

2.4.4.2 The system shall accept manual entry of organism identification and other additional microbiological information (i.e. gram stain and organism identification).

2.4.4.3 The system must have the capability to determine results by an automated optical reading system and computerized results database.

2.4.4.4 The system must have the capability for 16-24 hours throughput of bacterial identification and susceptibility testing.

2.4.4.5 Sufficient capacity and throughput to meet the volume and service demands as defined in the Price Schedule below.

2.4.4.6 The system must have a system volume capability range from 30-240 test kits depending on individual laboratory needs.

2.4.4.7 Safety features to avoid unnecessary exposure to bio-hazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

2.4.4.8 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system and additional equipment, such as middleware, needed to interface the analyzers. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

2.4.4.8.1 The accuracy of the barcode reading must have less than a 1% failure rate.

2.4.4.8.2 Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

2.4.4.8.3 Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric.

2.4.4.9 An operational system that is automated and provides continuous unattended testing throughout the day.

2.4.4.10 Minimal daily and periodic maintenance both in terms of hands on time and instrument down time.

2.4.4.11 The reading chambers must be modular in nature allowing for the isolation of a given problem without having to shut the entire system down.

2.4.5 Technical Features – The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following technical features:

2.4.5.1 Bar-Code System:

2.4.5.1.1 The system shall support bar-code recognition of inoculated samples at entry into the system and throughout testing.

2.4.5.2 Test Kit requirements:

2.4.5.2.1 Identification and susceptibility test kits shall be independent units.

2.4.5.2.2 The susceptibility test kits shall incorporate antimicrobial result concentrations in excess of the recommended break point ranges of the Clinical Laboratory Science Institute (CLSI) standards.

2.4.5.2.3 The systems on line result validation software should be capable of analyzing the antimicrobial results for the detection of resistance.

2.4.5.2.4 The test kits shall represent closed system once inoculated, thereby eliminating biohazard aerosol and/or spillage.

2.4.5.2.5 Sufficient test kits for routine quality control testing as well as quality control organisms shall be provided. QC organisms shall be provided at least twice annually.

2.4.5.3 The capability of accurately and reliably identifying gram negative, gram-positive bacteria, and yeast.

2.4.5.4 The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. At a minimum, the equipment must provide Minimum Inhibitory Concentrations (MIC) values for the following antibiotic-organism combinations.

(Note: This minimum capability requirement shall be updated by the Government and met by the contractor as new versions of standards are released):

Antibiotics Gram Positive Organism

Gram Negative Organisms

Pseudomonas

Fastidious Streptococcus

Yeast (Candida sp.)

Amikacin

Amp/Sulbactam

X

Aztreonam

Caspofungin

X

Cefazolin

X

Cefepime

Cefoxitin

X

Ceftazidime

Ceftriaxone

X

X

Cefuroxime

X

Cephalothin

X

X

X

Fluconazole

X

Imipenem

X

Meropenem

X

Piperacillin/Tazobactam

X

X

X

Tobramycin

X

Voriconazole

X

2.4.5.5 The capability of detecting emerging antimicrobial resistance.

2.4.5.6 The system shall have a comprehensive and extensive data base of bacteria and yeast species that is consistent with FDA/CLSI guidelines.

2.4.5.7 Contractor shall provide, when commercially available, software or equipment modifications at no additional cost to the Government as needed to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies. Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades.

2.4.5.8 The system shall offer a comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs.

NOTE: Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of quote.

2.4.5.9 The system shall offer detection of organisms that carry a carbapenemase enzyme.

2.4.5.10 The system shall be capable of producing an anti-biogram of organisms by selected body sites and collection/ordering locations.

2.4.5.11 The system shall have a built-in quality control program to regularly monitor system Performance.

2.4.6 Data Management System shall have the following:

2.4.6.1 The capability to record, store and print the following information:

· length of incubation

· time to completion

· required quality control and instrument maintenance information

· patient demographic information and specimen results

· detailed epidemiology reports

2.4.6.2 Capability of maintaining all data for up to 24 hours in the event of normal electrical power interruptions via battery backup.

2.4.6.3 Capability to backup all data to a secondary external storage format (e.g. compact disk).

2.4.6.4 Capability to record, store and print the following information: required quality control and instrument maintenance information, patient demographic information and specimen results.

2.4.6.5 Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms, etc.

2.4.6.6 Sufficient capacity to store patient information and test results for a period of 5 days with downloading capability to an external medium for long term storage of patient records and other information.

2.4.7 Hardware Features - The instrumentation shall have the following hardware features:

2.4.7.1 An on-board, adjustable monitor/screen that is easily readable.

2.4.7.2 A printer that has capability of printing a patient report with patient demographic information that includes at a minimum the patient’s name and accession or unique identifier number (UID).

2.4.7.3 An uninterruptible power supply for each instrument provided under this BPA.

2.4.7.4 The system shall have battery back-up capable of maintaining data in the event of a facility power failure.

2.4.7.5 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

2.4.8 Method Validation – The contractor shall be responsible for providing onsite support to assist with systems validation. The Contractor shall assist each site in the performance all comparison and validation studies to include any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, CAP standards, and Federal Regulations.

2.4.9 Reports- The Contractor shall provide to the Contracting Officer and the Contracting Officer Representative (COR at the VISN a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, as a minimum, total net sale, amounts before discount, and discount amounts by ordering facility along with the raw data that was used to generate the reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective Laboratory personnel. There will be no additional charges for any reports required as part of the BPA.

2.4.10 Support Features

2.4.10.1 Commercial marketing- The equipment models being offered shall be in current production as of the date this quote is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment.

2.4.10.2 Discontinued models that are only being made available as remanufactured equipment are not acceptable.

2.4.10.3 Start-Up Reagents- The Contractor shall provide all reagents, controls, McFarland Standards, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation shall be provided by the Contractor at no additional cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

2.4.10.4 Training- Upon Installation: The Contractor shall provide an instrument training program for at least two operators per facility at no charge to the Government that is coordinated with and timely with the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training as defined in the Contractor’s Cost Per Reportable Result Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair.

Additional Training in years 2 through 5: The Contractor shall provide training, at a minimum, for one operator per facility per year at the discretion of the Government for each model of instrumentation placed. The requested training resources should be flexible; this is the ability to share or combine training resources within the VISN sites. Training shall be provided at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

2.4.10.5 Equipment Preventative Maintenance/Repair Service: The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

2.4.10.5.1 A technical assistance center must be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hours.

2.4.10.5.2 Equipment repair service must be provided during core business hours. Normal business hours are 8:00 AM to 4:00 PM, Monday - Friday. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

2.4.10.5.3 Equipment response time shall be no more than 24 hours.

2.4.10.5.4 A minimum of 1 scheduled preventative maintenance call per year.

2.4.10.5.5 A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

· date and time notified

· date and time of arrival

· serial number, type and model number of equipment

· time spent for repair, and

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

2.4.10.6 Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability.

2.4.10.7 Ancillary support equipment - The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications:

2.4.10.7.1 Cabinetry to support/house the analyzer (if necessary)

2.4.10.7.2 Water systems (including consumable polishers, filters, etc.)

2.4.10.7.3 Universal interface equipment

2.4.10.7.4 Ancillary materials for test kits shall be provided at no additional charge.

2.4.10.7.5 Transfer tubes, disk type transfer tubes, sealer plugs, marking pens, pipette tips, pipette/diluter accessory kit and 12mm X 75 mm Polystyrene Tubes.

2.4.10.8 Interface Requirements:

2.4.10.8.1 The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (See Attachment A).

2.4.10.8.2 The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

2.4.10.8.3 If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

2.4.10.8.4 If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

2.4.10.8.5 If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

2.4.10.9 Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g. PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software.

2.4.10.10 Characterization of hazardous waste – The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

· Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

· Waste ignitability (Reference 40CFR261.21)

· Waste corrosivity (Reference 40CFR261.22)

· Waste reactivity (Reference 40CFR261.23)

· Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31)

· Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

2.4.10.10.1 The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.4.10.10.2 Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with Contractor response:

2.4.10.11 Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 60-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.4.10.11.1 Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

2.4.10.11.2 Contractors shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered sufficient cause to terminate this BPA for cause under the Termination for Cause clause of the BPA.

2.4.10.11.3 On June 1, 2019, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

2.4.11 Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or at the effectiveness level of 90% or more.

2.4.11.1 In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

2.4.11.2 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR.52.212-4 entitled “Termination for cause.” (The Contractor shall receive payment for acceptable tests reported during the 90-day acceptance period.)

2.4.11.3 Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure.

2.4.11.4 Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

2.4.11.5 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

2.4.11.6 The government will maintain daily records to satisfy the requirements of this paragraph and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.4.11.7 During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement.

2.4.12 Government’s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

2.4.13 Ownership of Equipment: Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer from the Government facility.

2.4.14 The Contractor will identify if removable media is required to perform their duties. The Bio-Med Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. If VA sensitive information is required to be downloaded to the contractor’s removable media, the contractor must use FIPS 140-2 encrypted devices and are required to have a BAA in place to cover the media sanitization requirements.

2.4.15 Prior to termination or completion of this BPA, Contractor/sub-Contractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/sub-Contractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA.

2.4.16 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/sub-Contractor or any person acting on behalf of the Contractor/sub-Contractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/sub-Contractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/sub-Contractor must self-certify that the media has been disposed of per 6500.1 requirements.

2.4.17 This must be completed within 30 days of termination or completion of the BPA or disposal or return of the IT equipment, whichever is earlier.

2.4.18 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

· Contractor must accept the system without the drive;

· VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

· VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

2.4.19 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

· The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

· Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA.

· A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

Cost per test reportables will be for clinical laboratories located at the following VISN 15 facilities:

VA Medical Center, 2401 West Main Street, Marion, IL 62959 VA Medical Center, 4801 Linwood Blvd, Kansas City, Mo 64128 VA Medical Center, 2200 Gage Blvd, Topeka, KS 66222 VA Medical Center, 1500 N. Westwood Blvd, Poplar Bluff, MO 63901 VA Medical Center, 800 Hospital Drive, Columbia, MO 65201 VA Medical Center, 915 N Grand Blvd, St. Louis, MO VA Medical Center, 5500 East Kellogg, Wichita, KS 67218

TEM NUMBER QUANTITY

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

0001 - 0007

Microbiology identification/susceptibility testing which includes: instruments, equipment, controls, consumables, reagents, supplies, and maintenance.

B.5 DELIVERY SCHEDULE

Kansas City VA Medical Center 4801 E Linwood Blvd Kansas City, MO 64128 2226

USA

913-946-1977 dana.seeler@va.gov

Topeka VAMC 2200 Gage Blvd, Warehouse Bld 20 Topeka, KS 66622 0001

USA

Wichita VAMC 5500 East Kellogg, BLDG 34 Wichita, KS 67218 1607

USA

Harry S Truman Memorial Veterans Hosp 800 Hospital Drive, BLDG D218 Columbia, MO 65201 5275

USA

Marion VAMC 2401 W Main Street Marion, IL 62959 1188

USA

Poplar Bluff VAMC 1500 N Westwood Blvd Poplar Bluff, MO 63901 3318

USA

ST. Louis VAMC, John Cochran 915 N Grand Blvd, BLDG 1 St Louis, MO 63106 1621

USA

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers.